Duns Number:069590113
Device Description: Intended to be used for medical purposes to inject fluid into or withdraw fluid from the b Intended to be used for medical purposes to inject fluid into or withdraw fluid from the body.
Catalog Number
-
Brand Name
SOL-M™ Allergy Syringe Tray
Version/Model Number
181027T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
be72bf9f-ccb6-46dc-96b2-d2e71841a7dc
Public Version Date
September 12, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
40818392014776
Quantity per Package
40
Contains DI Package
30818392014779
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 161 |